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1000 roses cc color plus correct sheer tan spf 30 - Medication Information

Product NDC Code 55560-0106
Drug Name

1000 roses cc color plus correct sheer tan spf 30

Type Brand
Active Ingredients
Zinc oxide 200 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name Andalou naturals
Packages
Package NDC Code Description
55560-0106-1 1 tube in 1 carton (55560-0106-1) / 58 ml in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Zinc Oxide 20%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Daily, alone or under make-up. Apply liberally 15 minutes before sun exposure and as needed. Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking. Use water resistant sunscreen if swimming or sweating. Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long sleeve shirts, pants and sunglasses. Children under 6 months: ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Non Medicinal Ingredients Aloe Barbadensis Leaf Juice Certified Organic/Organic , Purified Water (Aqua), Caprylic/Capric Triglycerides, Vegetable Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil , Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Polyglyceryl-2 Stearate, Helianthus Annuus (Sunflower) Seed Oil , Hydrogenated Castor Oil, Dimethicone, Magnesium Sulfate, Sorbitan Sesquioleate, Plant Stem Cells (Alpine Rose, Malus Domestica, Solar Vitis) and BioActive Berry Complex , Soothing Complex: [Sodium Hyaluronate, Magnolia Officinalis Bark Extract, Boswellia Serrata (Boswellin) Extract], Rosa Damascena (Rose) Flower Distillate , Rosa Canina (Rosehip) Fruit Oil , Punica Granatum (Pomegranate) Seed Oil , Borago Officinalis (Borage) Seed Oil , Iron Oxides, Zea Mays (Corn) Starch , Camellia Sinensis (White Tea) Leaf Extract Fair Trade/Biologique , Hibiscus Sabdariffa Flower Extract , Tocopherol, Phenethyl Alcohol, Ethylhexylglycerin, Rose Isolates, Vanilla Isolates, Pelargonium Graveolens (Rose Geranium) Flower Oil , Citrus Aurantium Dulcis (Orange) Peel Oil

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Helps prevent sunburn.

Purpose

Information about the drug product’s indications for use.
Purpose Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
1000 Roses CC Color Plus Correct Sheer Tan SPF 30 Zinc Oxide ZINC OXIDE ZINC OXIDE ALOE VERA LEAF WATER MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN JOJOBA OIL POLYHYDROXYSTEARIC ACID (2300 MW) POLYGLYCERYL-2 STEARATE SUNFLOWER OIL HYDROGENATED CASTOR OIL DIMETHICONE MAGNESIUM SULFATE, UNSPECIFIED FORM SORBITAN SESQUIOLEATE ROSA RUGOSA FLOWER APPLE VITIS VINIFERA SEED ACAI ARONIA MELANOCARPA FRUIT JUICE ARCTOSTAPHYLOS UVA-URSI LEAF VACCINIUM MYRTILLUS ANTHOCYANOSIDES EUROPEAN ELDERBERRY JUICE LYCIUM BARBARUM FRUIT ROSA CANINA FRUIT HIPPOPHAE RHAMNOIDES FRUIT HYALURONATE SODIUM MAGNOLIA OFFICINALIS BARK INDIAN FRANKINCENSE ROSA X DAMASCENA FLOWER ROSA MOSCHATA OIL POMEGRANATE SEED OIL BORAGE SEED OIL FERRIC OXIDE YELLOW STARCH, CORN WHITE TEA HIBISCUS SABDARIFFA FLOWER TOCOPHEROL PHENYLETHYL ALCOHOL ETHYLHEXYLGLYCERIN GERANIOL VANILLIN GERANIUM OIL, ALGERIAN TYPE ORANGE OIL, COLD PRESSED

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton NEW LOOK ANDALOU NATURALS NON GMO CC 1000 Roses ® COLOR + CORRECT Sheer Tan SPF 30 with Rose Stem Cells Soothing Resilience Broad Spectrum Protection FRUIT STEM CELL SCIENCE ® SENSITIVE NPN 80051191 2 fl oz e 58 mL PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Dist. by Andalou Naturals Novato, CA 94945 USA

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on damaged or broken skin.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions Call (888) 898-6955 or visit www.Andalou.com

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if rash or irritation develops and lasts.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product keep out of eyes. Rinse with water to remove.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information Protect the product in this container from excessive heat and direct sun.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API